QuadriplegiaNCT01958086
Visuomotor Prosthetic for Paralysis
A study testing Neural Communication System in people with Quadriplegia, run by Richard A. Andersen, PhD at 3 sites in United States.
Trial summary
The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Quadriplegia
- What is being tested?
- Neural Communication System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2013to 31 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology resulting in paralysis
- Age 22-65 years
- Able to provide informed consent
- Understand and comply with instructions, if necessary, with the aid of a translator
- Able to communicate via speech
- Surgical clearance
Show all 11Show fewer
- Life expectancy greater than 12 months
- Live within 60 miles of study location and willing to travel up to 5 days per week
- A regular caregiver to monitor the surgical site
- Psychosocial support system
- Stable ventilator status
Who cannot join
- Intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression if untreated
- Poor visual acuity
- Pregnancy
- Active infection or unexplained fever
- Scalp lesions or skin breakdown
Show all 21Show fewer
- HIV or AIDS infection
- Active cancer or chemotherapy
- Medically uncontrolled diabetes
- Autonomic dysreflexia
- History of seizure
- Implanted hydrocephalus shunt
- History of supratentorial brain injury or neurosurgery
- Medical conditions contraindicating surgery and chronic implantation of a medical device
- Unable to undergo MRI or anticipated need for MRI during study
- Nursing an infant or unwilling to bottle-feed infant
- Chronic oral or intravenous use of steroids or immunosuppressive therapy
- Suicidal ideation
- Drug or alcohol dependence
- Planning to become pregnant, or unwilling to use adequate birth control
- Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Ausaf Bari
- Recruiting
California Institute of Technology
Pasadena, California, 91125
- Recruiting
Casa Colina Centers for Rehabilitation
Pomona, California, 91769
Emily Rosario, PhD, 909-596-7733 ext. 3036, erosario@casacolina.org
About this study
The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of "smart" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.
Read the detailed description
The objective of the proposed research is to obtain scientific knowledge of visuomotor transformations in posterior parietal cortex (PPC) and primary motor cortex (M1) from tetraplegic subjects in a clinical trial to advance the development of neural prosthetics. We have shown in clinical trials conducted over the past 6 years that PPC can control neural prosthetics for assisting tetraplegic subjects. Other groups have concentrated on M1 and likewise find control for neural prosthetics. In our studies of PPC we have found that besides trajectory signals to move robotic limbs or control computer cursors, there are a plethora of visuomotor signals that represent intended movements of most of the body, movement goals, cognitive strategies, and even memory signals. Our central hypothesis is that PPC and M1 will encode visuomotor parameters in both similar and different ways, and that algorithms can be developed to leverage those signals from the two areas that are complimentary to improve prosthetic range and performance. Implants will be made in both M1 and PPC, enabling simultaneous recording in the same subjects, elevating concerns of comparing data from different labs collected in different individuals with different implants and different tasks.
This central hypothesis will be tested in two broad aims, for which we have substantial preliminary data. Aim 1 will examine the control of the body by the two areas. It is hypothesized that M1 will demonstrate strong specificity for the contralateral limb (implants will be made in the hand knob) whereas PPC will code movements for most of the body and on both contra and ipsilateral sides by leveraging its partially mixed encoding of parameters (subaim 1a). Whereas M1 is hypothesized to code spatial variables exclusively during attempted or imagined actions, it is hypothesized that PPC also encodes cognitive spatial variables in task appropriate reference frames (subaim 1b). In subaim 1c we will examine how multiple body parts are combined in movement representations, hypothesizing that M1 and PPC will employ a diverse set of mechanisms including linear summation, non-linear combinations, and movement suppression expressed in different ways as a function of brain area and the specific movement set.
Aim 2 will examine the temporal aspects of encoding in the two areas. In subaim 2a we will test the hypothesis that the neural dynamics during sustained periods of movement are largely unchanging in both areas. In subaim 2b we hypothesize that, during sequential movements, M1 codes only the ongoing movement whereas PPC codes both the current and subsequent movements. Finally, in subaim 2c we will examine the coding of movement speed, with the hypothesis that there are separate subspaces in both M1 and PPC for direction and speed of movement.
- Conditions
- Quadriplegia
- Being tested
- Neural Communication System
- Keywords
- Neural, Prosthetic, brain machine interface, brain computer interface, brain control, paralysis, tetraplegia, quadriplegia, spinal cord injury
- Medical subject headings
- Quadriplegia, Paralysis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Communication SystemDevice
Also called NeuroPort Multi-Port Array
NeuroPort Arrays allow for the local recording of cerebral cortex. The Neural Communication system is primarily composed of two NeuroPort Arrays. The two arrays of one MultiPort device will be placed in the primary motor cortex for recording (Platinum-tipped electrodes); and the two arrays of the additional MultiPort device be placed in the superior parietal lobule for recording (Platinum-tipped electrodes). Each MultiPort device consists of two arrays, each with 100 electrodes in a 10 x 10 configuration, with dimensions 4 mm x 4 mm x 1.5 mm (W x H x D) or 4 mm x 4 mm x 1.0 mm, and a titanium percutaneous connector, 19 mm diameter at the base. Each MultiPort can have a total of 128 active channels (capable of transmitting neural signals to the percutaneous connector) across the two arrays. In our design, we will split active channels evenly between the two arrays resulting in 64 active channels per array.
| Study group | Role | What they receive |
|---|---|---|
| Neural Communication System | Experimental | The Neural Communication System consists of two Neuroport Multi-Port Arrays, which are descried in detail in the intervention description. One Neuroport Multi-Port Array is inserted into the posterior parietal cortex, an area of the brain used in reach planning. The second Neuroport Multi-Port Array is inserted into the motor cortex, which is primarily responsible for controlling movement. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to use thought to control a simple computer environment or a tablet computer. Receives: Device: Neural Communication System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject control of a tablet computer
Assessments will be compared with chance and previous reports of BMI efficacy using control signals derived from primary motor cortex. Computer-interface competency examination that measures the ability of the subject to control various aspects of the tablet user interface. Additionally we will measure the Quality of Life Inventory (QOLI) at regular intervals over the duration of the study. Changes in performance over time.
Measured: Six years after array implantation
Absence of infection or irritation
The Serious Adverse event (SAE) rate will be calculated as the number of SAEs per implant-days. The SAE rate will be continuously compared to the 1% threshold level. CT scan; inspection of patient's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms.
Neurologic exam will be compared to baseline neurologic exam
Measured: Six years after array implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start1 Oct 2013
- Primary completion30 Apr 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for QuadriplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard A. Andersen, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Casa Colina Hospital and Centers for Healthcare
- Responsible party
- Sponsor-investigator, Richard A. Andersen, PhD, California Institute of Technology
- Investigators
- Richard A Andersen, PhD, Principal investigator, California Institute of TechnologyAusaf Bari, MD, PhD, Principal investigator, University of California, Los AngelesEmily Rosario, PhD, Principal investigator, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958086
- Sponsor's protocol ID
- G120287
- Other IDs
- 13-000576
- Status last verified
- Mar 2026
- First submitted
- 4 Oct 2013
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Revechkis B, Aflalo TN, Pouratian N, Rosario E, Ouellette DS, Zhang C, Pejsa K. Effector specificity in human posterior parietal neurons and local field potentials during movement in virtual reality and online brain control. J Neural Eng. 2025 Mar 31;22(2):10.1088/1741-2552/adc3ca. doi: 10.1088/1741-2552/adc3ca.
PubMed 40117671Bashford L, Rosenthal IA, Kellis S, Bjanes D, Pejsa K, Brunton BW, Andersen RA. Neural subspaces of imagined movements in parietal cortex remain stable over several years in humans. J Neural Eng. 2024 Aug 28;21(4):046059. doi: 10.1088/1741-2552/ad6e19.
PubMed 39134021Guan C, Aflalo T, Zhang CY, Amoruso E, Rosario ER, Pouratian N, Andersen RA. Stability of motor representations after paralysis. Elife. 2022 Sep 20;11:e74478. doi: 10.7554/eLife.74478.
PubMed 36125116
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visuomotor Prosthetic for Paralysis
- ClinicalTrials.gov ID
- NCT01958086
- Acronym / sponsor ID
- G120287
- Conditions
- Quadriplegia
- Keywords
- Neural, Prosthetic, brain machine interface, brain computer interface, brain control, paralysis, tetraplegia, quadriplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Richard A. Andersen, PhDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Casa Colina Hospital and Centers for Healthcare
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of "smart" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.
Detailed description
The objective of the proposed research is to obtain scientific knowledge of visuomotor transformations in posterior parietal cortex (PPC) and primary motor cortex (M1) from tetraplegic subjects in a clinical trial to advance the development of neural prosthetics. We have shown in clinical trials conducted over the past 6 years that PPC can control neural prosthetics for assisting tetraplegic subjects. Other groups have concentrated on M1 and likewise find control for neural prosthetics. In our studies of PPC we have found that besides trajectory signals to move robotic limbs or control computer cursors, there are a plethora of visuomotor signals that represent intended movements of most of the body, movement goals, cognitive strategies, and even memory signals. Our central hypothesis is that PPC and M1 will encode visuomotor parameters in both similar and different ways, and that algorithms can be developed to leverage those signals from the two areas that are complimentary to improve prosthetic range and performance. Implants will be made in both M1 and PPC, enabling simultaneous recording in the same subjects, elevating concerns of comparing data from different labs collected in different individuals with different implants and different tasks.
This central hypothesis will be tested in two broad aims, for which we have substantial preliminary data. Aim 1 will examine the control of the body by the two areas. It is hypothesized that M1 will demonstrate strong specificity for the contralateral limb (implants will be made in the hand knob) whereas PPC will code movements for most of the body and on both contra and ipsilateral sides by leveraging its partially mixed encoding of parameters (subaim 1a). Whereas M1 is hypothesized to code spatial variables exclusively during attempted or imagined actions, it is hypothesized that PPC also encodes cognitive spatial variables in task appropriate reference frames (subaim 1b). In subaim 1c we will examine how multiple body parts are combined in movement representations, hypothesizing that M1 and PPC will employ a diverse set of mechanisms including linear summation, non-linear combinations, and movement suppression expressed in different ways as a function of brain area and the specific movement set.
Aim 2 will examine the temporal aspects of encoding in the two areas. In subaim 2a we will test the hypothesis that the neural dynamics during sustained periods of movement are largely unchanging in both areas. In subaim 2b we hypothesize that, during sequential movements, M1 codes only the ongoing movement whereas PPC codes both the current and subsequent movements. Finally, in subaim 2c we will examine the coding of movement speed, with the hypothesis that there are separate subspaces in both M1 and PPC for direction and speed of movement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural Communication System | Experimental | Device: Neural Communication SystemThe Neural Communication System consists of two Neuroport Multi-Port Arrays, which are descried in detail in the intervention description. One Neuroport Multi-Port Array is inserted into the posterior parietal cortex, an area of the brain used in reach planning. The second Neuroport Multi-Port Array is inserted into the motor cortex, which is primarily responsible for controlling movement. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to use thought to control a simple computer environment or a tablet computer. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathology resulting in paralysis
- Age 22-65 years
- Able to provide informed consent
- Understand and comply with instructions, if necessary, with the aid of a translator
- Able to communicate via speech
Key exclusion criteria (21 listed)
- Intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression if untreated
- Poor visual acuity
- Pregnancy
- Active infection or unexplained fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Communication SystemAlso: NeuroPort Multi-Port ArrayNeuroPort Arrays allow for the local recording of cerebral cortex. The Neural Communication system is primarily composed of two NeuroPort Arrays. The two arrays of one MultiPort device will be placed in the primary motor cortex for recording (Platinum-tipped electrodes); and the two arrays of the additional MultiPort device be placed in the superior parietal lobule for recording (Platinum-tipped electrodes). Each MultiPort device consists of two arrays, each with 100 electrodes in a 10 x 10 configuration, with dimensions 4 mm x 4 mm x 1.5 mm (W x H x D) or 4 mm x 4 mm x 1.0 mm, and a titanium percutaneous connector, 19 mm diameter at the base. Each MultiPort can have a total of 128 active channels (capable of transmitting neural signals to the percutaneous connector) across the two arrays. In our design, we will split active channels evenly between the two arrays resulting in 64 active channels per array. | Device | Neural Communication System |
Primary outcome
Subject control of a tablet computer
Time frame: Six years after array implantation
Assessments will be compared with chance and previous reports of BMI efficacy using control signals derived from primary motor cortex. Computer-interface competency examination that measures the ability of the subject to control various aspects of the tablet user interface. Additionally we will measure the Quality of Life Inventory (QOLI) at regular intervals over the duration of the study. Changes in performance over time.
Absence of infection or irritation
Time frame: Six years after array implantation
The Serious Adverse event (SAE) rate will be calculated as the number of SAEs per implant-days. The SAE rate will be continuously compared to the 1% threshold level. CT scan; inspection of patient's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms. Neurologic exam will be compared to baseline neurologic exam
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 40117671Revechkis B, Aflalo TN, Pouratian N, Rosario E, Ouellette DS, Zhang C, Pejsa K. Effector specificity in human posterior parietal neurons and local field potentials during movement in virtual reality and online brain control. J Neural Eng. 2025 Mar 31;22(2):10.1088/1741-2552/adc3ca. doi: 10.1088/1741-2552/adc3ca.
- Derived from this study: PubMed 39134021Bashford L, Rosenthal IA, Kellis S, Bjanes D, Pejsa K, Brunton BW, Andersen RA. Neural subspaces of imagined movements in parietal cortex remain stable over several years in humans. J Neural Eng. 2024 Aug 28;21(4):046059. doi: 10.1088/1741-2552/ad6e19.
- Derived from this study: PubMed 36125116Guan C, Aflalo T, Zhang CY, Amoruso E, Rosario ER, Pouratian N, Andersen RA. Stability of motor representations after paralysis. Elife. 2022 Sep 20;11:e74478. doi: 10.7554/eLife.74478.
Related trials for Quadriplegia
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
Recruiting
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Tetraplegia/Tetraparesis
Recruiting
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard A Andersen, PhD principal investigator
California Institute of Technology
Ausaf Bari, MD, PhD principal investigator
University of California, Los Angeles
Emily Rosario, PhD principal investigator
Casa Colina Hospital and Centers for Healthcare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Communication System in people with Quadriplegia, run by Richard A. Andersen, PhD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ausaf Bari, MD, PhD (310-825-5111, ABari@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject control of a tablet computer (time frame: Six years after array implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958086, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.